Adult Oxygen Mask High Concentration

GUDID 50628725096921

High Concentration, 7ft. Saflo Tube - multi-fit on one end

Canadian Hospital Specialties Limited

Rebreathing oxygen face mask
Primary Device ID50628725096921
NIH Device Record Key6f512a4e-bc16-4bd8-9c31-0e4459d25b95
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult Oxygen Mask High Concentration
Version Model NumberR-2450SM
Company DUNS240992693
Company NameCanadian Hospital Specialties Limited
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com
Phone9058259300
EmailRegulatory.affairs@chsltd.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100628725096926 [Primary]
GS150628725096921 [Package]
Contains: 00628725096926
Package: Corrugate Case [50 Units]
In Commercial Distribution

FDA Product Code

KGBMask, Oxygen, Non-Rebreathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-04
Device Publish Date2024-02-23

Devices Manufactured by Canadian Hospital Specialties Limited

50628725099755 - PEDIATRIC HIGH CONCENTRATION OXYGEN MASK2024-11-15 PEDIATRIC HIGH CONCENTRATION OXYGEN MASK
50628725098208 - VixOne™ Nebulizer Kit 2024-08-28 UP-DRAFT BOTTOM CONNECTION NEBULIZER VIXONE WITH 7ft SAFLO
00628725097169 - Oxygen Wrench2024-07-29 OXYGEN WRENCH
50628725097621 - Oxygen Wrench2024-07-29 OXYGEN WRENCH WITH SECURITY CHAIN
50628725000195 - Med-Rx2024-07-25 MICROBORE TUBING (I.D 0.023") W/ PINCH CLAMP, M/F LL.
50628725000218 - Med-Rx2024-07-25 MINIBORE TUBING (I.D 0.050") W/ SLIDE CLAMP, M/F LL.
50628725000232 - Med-Rx2024-07-25 MINIBORE TUBING (I.D 0.050") W/ SLIDE CLAMP, M/F L.L.
50628725000379 - Med-Rx2024-07-25 STANDARD BORE TUBING (I.D 0.095") W/ PINCH CLAMP, M/F LL

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